510(k) Report

Devices descending from K151921

3 later devices reach Sterispine PS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201648Sterispine™ PSSafe Orthopaedics202011
+1K170528Sterispine™ PSSafe Orthopaedics20172—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—